MAUDE Adverse Event Report: SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., DRIVE; BED

Model Number	15033BV-PKG-T
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving an electric bed by an end user, who stated that "they were laying with the remote under her right hip and the remote control got hot and burned her." the end user went to a telehealth appointment where she reportedly told that she was "on the verge of a 1st degree burn" and prescribed ointment for treatment.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving an electric bed by an end user, who stated that "they were laying with the remote under her right hip and the remote control got hot and burned her." the end user went to a telehealth appointment where she reportedly told that she was "on the verge of a 1st degree burn" and prescribed ointment for treatment.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: BED
• Manufacturer (Section D): SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO.,; #259 jiugan road; sijing town; song jiang district, shanghai 20161 ; CH 20161
• MDR Report Key: 16442735
• Report Number: 2438477-2023-00012
• Device Sequence Number: 14920935
• Product Code: FNL
• UDI-Device Identifier: 00822383211848
• UDI-Public: 00822383211848
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023
• Report Date (Section F): 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 15033BV-PKG-T
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/30/2023
• Device Age: 6 YR
• Date Report to Manufacturer: 03/13/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 04/04/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Date Report Sent to FDA: 02/27/2023